• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT DIABETES CARE INC FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71562-01
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/30/2019
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation. A follow-up report will be submitted once additional information is obtained. The date of event is unknown. The date entered is the date abbott diabetes care became aware of the event. The device mfg date is unknown. The date entered is the date abbott diabetes care became aware of the event. All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A healthcare profession called to report that customer experiencing pain and upon removal of the freestyle libre pro sensor, it was noticed that portion of the filament had broken and left in the customer¿s body which required medical intervention. A surgical procedure was performed to remove the filament and no further treatment was reported. There was no report of death or permanent impairment associated with this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFREESTYLE LIBRE PRO
Type of DeviceFLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
tara williamson
1360 south loop road
alameda, CA 94502-7001
5108644472
MDR Report Key9214113
MDR Text Key163018692
Report Number2954323-2019-08137
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P150021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71562-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/21/2019 Patient Sequence Number: 1
-
-